Trillium Gift of Life (Trillium), the agency that oversees transplants in Ontario, has announced the launch of a pilot project that will make patients with alcoholic liver disease eligible for a transplant without first having to be sober for six months. The announcement comes in the wake of a legal challenge filed by the widow of a man who passed away after being denied a transplant.

The Pilot Project

The study will last three years, starting in August 2018, and will take place at Ontario’s two liver-transplant centres: University Health Network (UHN) in Toronto, and London Health Sciences Centre, in London.

Over the course of the study, Trillium expects to provide transplants to almost 100 patients with alcoholic liver disease, approximately 26 to 39 patients annually, about 10-15% of total liver transplants now. The agency plans to hire specialized psychiatrists, nurses, and other health professionals to provide addiction treatment with the hope that the treatment will lessen the odds of remission.

Individual hospitals in both the United States and Europe have attempted similar experiments in the past, but the Ontario project is likely the first effort by any large jurisdiction to overturn the longstanding six-month sober rule.

A Trillium spokeswoman told the National Post that the agency is finalizing the pilot project and acquiring necessary funding. The goal is to “determine if there is an evidence-based basis to change the criteria”, but that, in the meantime, the listing criteria for liver transplants remain unchanged.

The Six-Month Sober Rule

Ethicists at UHN have defended the requirement to be six months sober before being eligible for a liver transplant by arguing that the rule exists to ensure that recipients “take good care of a precious resource”, and to show “respect” to the organ donor and the donor family.

The reasoning is that prolonged sobriety may alleviate a patient’s alcoholic liver disease, making the transplant unnecessary, and could ensure better results post-transplant.

The Constitutional Challenge

Debra Selkirk, the woman behind the constitutional challenge, filed her claim in 2015, after her husband, Mark, died after doctors refused to give him a transplant until he had first been sober for six months.

Mark had been diagnosed with advanced alcoholic hepatitis and doctors informed him that a transplant could potentially save him. Debra, as well as several other family members, appeared to be matches and were willing to give up parts of their liver to help Mark. However, UHN refused to do the operation until Mark had not had a drink for six months. Mark died within two weeks of his diagnosis.

Debra’s claim named UHN, Trillium, and the Ministry of Health, as defendants. The claim argued that the six-month sober rule violates the right to life, liberty, and security of the person, essentially condemning hundreds of alcoholic patients to death for “no justifiable reason”. She also argued that the rule violates the Charter’s equality guarantee since other patients who have lifestyle-related diseases are not forced to change their habits before they can be eligible for a transplant.

The claim questioned the scientific evidence behind the six-month rule and the reasoning widely used to defend it. It cited a 2013 journal paper by six Canadian experts, two of whom site on the advisory bodies that guide Trillium in its transplant decision-making.

The paper called for the six-month rule to be reviewed, stating that most alcoholic transplant recipients who start drinking after their transplant consume minimal amounts of alcohol that are unlikely to ruin their new organ. The paper also notes that there is no similar rule preventing, for instance, intravenous drug users with Hepatitis C from obtaining a liver transplant, or denying a transplant to obese patients with fatty-liver disease, stating:

Surely patients in a just society should not be penalized for having a genetic predisposition to a potentially fatal disease.

The claim also pointed to guidelines from the American Association for the Study of Liver Disease which similarly question the six-month sober rule, noting that transplant rejection and survival rates are similar between recipients with alcohol related disease and other recipients.

After initially vigorously fighting Debra’s challenge, lawyers for the province approached her last May and convinced her to put her case on hold while transplant listing criteria were reviewed. The lawyers admitted that the research Debra presented “did not necessarily bolster their position”. Debra ended up pulling out of the agreement she made with the lawyers after a series of delay and backtracks. However, in the meantime, Trillium agreed to the pilot project.

What Will This Mean Going Forward?

Debra told the National Post that she is happy to have had at least a temporary effect on what she previously viewed as an “immutable policy”:

I’m very proud that up to 97 or 98 people will get the opportunity to have a new life…[a]nd I’m very hopeful the practice will continue.

This pilot project will likely have a deep impact on patients with alcohol related liver disease. Currently, approximately 2,800 Canadians with alcoholic liver disease die annually. This project may decrease those numbers.

We will continue to follow developments in this matter, and will provide updates as they become available.

At Wise Health Law, we provide exceptional guidance on health law matters to public hospitals and other health-care organizations across the province. We monitor trends and developments in health care, medicine, and health law so that we can provide forward-thinking legal and risk management advice to each of our clients. Contact us online, or at 416-915-4234 for a consultation.

Author

Written on behalf of Wise Health Law

Date

September 19, 2017

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